As an estimated 6,000 American women reach menopause every day, prescriptions for less-regulated hormone therapies are reaching the number of those for Food and Drug Administration (FDA)-approved medications to alleviate symptoms and discomfort associated with menopause. Dr. JoAnn Pinkerton, professor of OB-GYN, suggests more regulation and education for compounded hormone therapies.
Pinkerton, a gynecologist and specialist in women’s midlife health, said she believes that compounded hormones pose unique risks due to the loose parameters surrounding drug purity and safety. However, she said that both FDA-approved hormone therapies and compounded hormones, those which are manufactured in private pharmacies without FDA regulation, are essential in providing a variety of effective medications for women going through menopause.
“The biggest difference is that the former, the FDA approved therapies, are regulated by the FDA, which means that when they are manufactured, they are tested for purity and potency and they are sold with is called a ‘label’, FDA-approved labeling which includes product information which may include black box warnings,” Pinkerton said. “In particular, to get something through the FDA, it requires rigorous, randomized clinical trials. You have to meet certain efficacy and safety data, and you have to have peer review of those published reports before something can get through the FDA.”
Compounded bioidentical hormones are menopausal therapies produced and packaged in pharmaceutical laboratories that are meant to restore estrogen and progesterone hormone levels that are lost during menopause. The main reasons women are prescribed compounded hormones over FDA-approved therapies are product allergies and convenience of application.
For example, some FDA-approved bioidentical hormones contain peanut oil. For a woman who is allergic to peanuts, a compounded therapy would be safer, because it can be produced with soy or yams instead. Additionally, compounded therapies are often made into creams, pills or gels, while FDA-approved hormones are more limited in application.
However, non-FDA-regulated hormone products do not require labels informing the patient of the product’s ingredients or risks. The essential issues with compounded hormones are the varying levels of estrogen and progesterone and risk of contaminants, leading to health complications including an elevated risk for endometrial cancer. Because of this, Pinkerton emphasized that compounded hormones must have stricter regulations and should be used with caution.
“My medical recommendation is similar to what all the major medical societies have recommended, which is that FDA approved therapies should be used first line, and that if someone has a specific reason that they can’t tolerate an FDA product or it doesn’t meet their needs, then they should look to accredited compounding pharmacies to meet a patient’s specific need,” Pinkerton said.
Ultimately, Pinkerton said she believes that both safe compounded hormones and FDA-regulated therapies improve women’s quality of life substantially.
“If you’re having 50 hot flashes a week, you’re waking up soaking with sweat, three times a night, and now you’re having maybe one hot flash once a day and you’re able to sleep through the night or sleep most nights, that’s a pretty dramatic improvement,” Pinkerton said.
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